Semax^® (Drops) Instructions for Use

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

A synthetic peptide that is an analogue of the ACTH_4-10 fragment (Methionyl-glutamyl-histidyl-phenylalanyl-prolyl-glycyl-proline), completely devoid of hormonal activity. All amino acids are in the L-form.

It has an original mechanism of neurospecific action on the central nervous system. It is a synthetic analogue of corticotropin, possessing nootropic properties and completely devoid of hormonal activity. It affects processes related to memory formation and learning.

It enhances attention during learning and information analysis, improves memory trace consolidation in patients after neurosurgical interventions, traumatic brain injury, and those suffering from cerebrovascular diseases, including dyscirculatory encephalopathy; improves the body’s adaptation to hypoxia, cerebral ischemia, anesthesia, and other damaging effects.

It is practically non-toxic upon single and long-term administration. It does not exhibit allergic, embryotoxic, teratogenic, or mutagenic properties. It does not have a local irritant effect.

Pharmacokinetics

It is absorbed from the nasal mucosa, with up to 60-70% absorbed in terms of the active substance. It is rapidly distributed to all organs and tissues and penetrates the blood-brain barrier. Upon entering the bloodstream, it undergoes rapid biotransformation and is excreted from the body in the urine.

Indications

• Intellectual-mnestic disorders in vascular brain lesions;
• Recovery period after stroke;
• Dyscirculatory encephalopathy;
• Transient cerebral circulatory disorders (TIAs);
• Conditions after traumatic brain injury, neurosurgical operations, and anesthesia;
• Neurotic disorders of various origins, including after ionizing radiation;
• To increase the body’s adaptive capabilities in extreme situations;
• For the prevention of mental fatigue;
• During monotonous operator activity;
• Work under stressful conditions.

In ophthalmology

• Optic nerve atrophy;
• Optic neuritis of inflammatory or toxic-allergic etiology.

In pediatrics

• As a nootropic agent in children aged 7 years and older for the treatment of minimal brain dysfunctions (including ADHD – attention deficit hyperactivity disorder).

ICD codes

Dosage Regimen

Drops

Administered intranasally.

One drop of the standard solution contains 50 mcg of the active substance. The drug solution is administered using a pipette into each nasal passage in an amount of no more than 2-3 drops. If it is necessary to increase the dose, administration is carried out in several steps with intervals of 10-15 minutes.

For intellectual-mnestic disorders in vascular brain lesions, dyscirculatory encephalopathy, transient cerebral circulatory disorders, a single dose is 200-2000 mcg (based on 3-30 mcg/kg). The daily dose is 800-8000 mcg (based on 7-70 mcg/kg). The drug is prescribed as 2-3 drops into each nasal passage 4 times/day for 10-14 days; if necessary, the course of treatment is repeated.

After traumatic brain injury, neurosurgical operations, and anesthesia, a single dose is 1400-3500 mcg (40-50 mcg/kg) 3 times/day for 3-5 days. If necessary, the course of treatment is extended to 14 days.

To increase the body’s adaptive capabilities and prevent mental fatigue – for 3-5 days, 2-3 drops into each nasal passage 2-3 times in the first half of the day. The daily dose is 400-900 mcg. If necessary, the course of treatment is repeated.

For optic nerve diseases, the drug is instilled as 2-3 drops into each nasal passage 2-3 times/day. The daily dose is 600-900 mcg. The course of treatment is 7-10 days. Additionally, the drug can be administered via endonasal electrophoresis; the drug is administered from the anode; current strength – 1 mA; exposure duration – 8-12-15 min. The daily dose is 400-600 mcg. The course of treatment is 7-10 days.

For children aged 7 years and older with minimal brain dysfunctions, 1-2 drops are prescribed into each nasal passage (based on 5-6 mcg/kg) 2 times/day (morning and afternoon). The daily dose is 200-400 mcg. The course of treatment is 30 days.

Adverse Reactions

With long-term use, mild irritation of the nasal mucosa is possible.

Contraindications

• Acute mental conditions;
• Disorders accompanied by anxiety;
• History of seizures;
• Children under 7 years of age;
• Hypersensitivity to the drug components.

Use in Pregnancy and Lactation

Use during pregnancy and lactation is contraindicated, as clinical studies have not been conducted.

Pediatric Use

Contraindicated in children under 7 years of age; in ophthalmological and neurosurgical practice – in children and adolescents under 18 years of age.

Special Precautions

Use in pediatrics

Use in children and adolescents under 18 years of age in ophthalmological and neurosurgical practice is contraindicated. Clinical studies have not been conducted.

Drug Interactions

Pharmaceutical

Based on the chemical structure, chemically incompatible combinations are not expected: it is rapidly destroyed and does not enter the gastrointestinal tract.

Pharmacokinetic

Considering the chemical structure (heptapeptide – a synthetic analogue of ACTH, completely devoid of hormonal activity), the rapidity of absorption and rate of entry into the bloodstream, as well as the intranasal route of administration, the influence of other drugs on pharmacokinetic parameters is not expected.

Considering the route of administration, the administration of agents with local vasoconstrictive action via their intranasal administration is undesirable.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.